Label: CLARUS ANTIFUNGAL- tolnaftate cream

  • NDC Code(s): 44577-470-00
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • Drug Facts

  • Active Ingredient

    Tolnaftate 1 %

  • Purpose

    Anti-fungal

  • Uses:

    For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).  Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.

  • Warnings:

    For external use only. Avoid contact with the eyes.

    Do not use

    on children under 2 years of age unless directed by a physician.

    Stop use and ask physician if:

    • When using for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.
    • When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician.

    If pregnant or breast-feeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    For treatment of athlete's foot and ringworm:

    • Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician.
    • Supervise children in the use of this product.
    • For athlete's foot:Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • For athlete's foot and ringworm:Use daily for 4 weeks. If condition persists longer, consult a physician. This product is not effective on scalp or nail infections.
    • To prevent athlete's foot:
    • Clean the feet and dry thoroughly.
    • Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
    • Supervise children in the use of this product.
    • Pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once daily.
  • Other information:

    Store between 20º -25ºC (68º -77ºF)

  • Inactive ingredients:

    Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CLARUS ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-470
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-470-001 in 1 BOX03/11/2024
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03/11/2024
    Labeler - Clinical Therapeutic Solutions (078402750)